BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS SEMI-RIGID ANNULOPASTY RING

    MDR report key: 6016047 · Received October 11, 2016

    Report

    Report Number
    2025587-2016-01600
    Event Type
    Injury
    Date Received
    October 11, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K072655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. WITHOUT THE RECEIPT OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE TO MITRAL REGURGITATION. IT WAS REPORTED THAT THE POSTERIOR CHORDEA WERE ELONGATED AND ULTIMATELY CAUSED THE REPAIR TO BE INCOMPETENT. THE PHYSICIAN ATTRIBUTED THE FAILED REPAIR TO THE PATIENT'S NATIVE VALVE AND STATED THAT THERE WAS NO MALFUNCTION WITH THIS ANNULOPLASTY RING. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668804 SIMULUS SEMI-RIGID ANNULOPASTY RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 800

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention